N/A
N=80
Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis
Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT02191046 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children — 6.56; 6.89; 2.17; 1.24 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- squeezable bottle (Device); syringe 20 ml (Device)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Thammasat University
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children |
6.56; 6.89; 2.17; 1.24; 5.11; 5.97 | <0.05 sig |
| SECONDARY the Contamination in Nasal Irrigation Devices |
— | — |
Summary
The purpose of this study is to the effect of squeezable bottle nasal irrigation device with syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation
Eligibility Criteria
Inclusion Criteria
- age 3-15 years
- diagnose sinusitis by each of following criteria 2.1 persistent upper respiratory infection symptoms > or = 10 days 2.2. severe upper respiratory infection symptom with greenish discharge per nose or periorbital swelling 2.3 double sickening of upper respiratory infection symptoms
Exclusion Criteria
- patient who has history of penicillin allergy
- patient who has complication of sinusitis
- patient with a history of nasal anatomical defects
- patient who has immune deficiency or primary ciliary dyskinesia
Data sourced from ClinicalTrials.gov (NCT02191046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.